|- candidate number||9449|
|- NTR Number||NTR2908|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-mei-2011|
|- Secondary IDs||10/338 METC AMC|
|- Public Title||The MIC trial: Microbiota and immune cells in IBD.|
|- Scientific Title||In depth characterization of the mucosal microbiota in patients with IBD using novel, potent high-throughput approaches and their interaction with the immune system.|
|- ACRONYM||MIC trial|
|- hypothesis||We hypothesize that the perturbed interplay between certain constituents of the microbiota and the host is caused by invading organisms, which after crossing the epithelial barrier are capable of inciting and/or persisting an unbalanced innate immune response because clearing of microorganisms is impaired by dysfunction of the local housekeeping cells of the innate immunity.|
|- Healt Condition(s) or Problem(s) studied||Inflammatory bowel disease, Microbiotica, Immune cells|
|- Inclusion criteria||1. Patients ≥18 years or older;|
2. Established Crohn’s disease, ulcerative colitis and CRC patients not known with IBD who undergo intestinal resection;
3. Patients with active left-sided ulcerative colitis or Crohn’s colitis who are scheduled for diverting ostomy.
|- Exclusion criteria||1. Ischemia of the bowel;|
2. Positive stool cultures or parasite tests for common enteric pathogens;
3. Use of Antibiotics in preceding 4 weeks;
4. Use of probiotics in preceding 8 weeks;
5. Radiation therapy within 4 weeks before surgery;
6. Chemotherapy within 4 weeks before surgery.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||15-mrt-2011|
|- planned closingdate||15-mrt-2013|
|- Target number of participants||88|
|- Primary outcome||1. Intra-individual differences between inflamed and non-inflamed tissue in presence of microbial DNA in specific microenvironmental spaces; differences between IBD patients and controls;|
2. Intra-individual differences in presence of microbial DNA in specific microenvironmental spaces of sigmoid mucosa before and 12 weeks after diverting ostomy;
3. Identify adaptive and innate immune cells producing cytokines involved in IBD.
|- Secondary outcome||1. Presence of microbial DNA in granuloma’s of CD patients;|
2. Assessment of co-localisation between invading microbes and lamina propria macrophages dendritic cells using FISH probes;
3. Alterations between inflamed and non-inflamed tissue between patients and controls of phagosome maturation and autophagy, as well as apoptosis of mucosal macrophages and dendritic cells in IBD;
4. Assessment of signalling between innate lymfoid cell (ILC) subsets and lamina propria macrophages dendritic cells;
5. Assessment of ILC’s subpopulations in peripheral blood.
|- Timepoints||Diverting ostomy group: Week 0, 12.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| N.G.M. Rossen|
|- CONTACT for SCIENTIFIC QUERIES|| N.G.M. Rossen|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|The BROAD Foundation|
|- Brief summary||Inflammatory bowel disease (IBD) consists of Crohn’s disease (CD) and ulcerative colitis (UC). The current prevailing hypothesis states that the pathogenesis involves an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal microbiota in a genetically predisposed individual. However, it is not known which constituents of the microbiota and which components of the innate and adaptive immune response are involved. The human microbiota forms a complex ecosystem with its host and may comprise more than 1800 phylotypes.|
The aim of our project is in-depth characterization of the microbiota components both adjacent to and within the mucosa in patients with IBD, by applying novel high-throughput analysis technology in a global description strategy approach. Furthermore, we aim to assess the interaction between invading microorganisms, local housekeeping cells and the adaptive and innate immune system in the intestine.
|- Main changes (audit trail)|
|- RECORD||20-mei-2011 - 4-jun-2011|